Diagnostic testing device for the skin

ABSTRACT

A diagnostic testing device for the skin, comprising at least one compartment (3) for the accommodation of a diagnostic aid, and adhesive strip (1) on which the compartment is accommodated, and a removable protective strip (4) which is stuck to the adhesive strip at the same side as the compartment. The protective strip is provided with an opening (7) at the position of each compartment.

FIELD OF THE INVENTION

The invention relates to a diagnostic testing device for the skin,comprising at least one compartment for the accommodation of adiagnostic aid, an adhesive strip on which the compartment isaccommodated, and a removable protective strip which is stuck to theadhesive strip at the same side as the compartment.

BACKGROUND OF THE INVENTION

Such a testing device is known from Dutch Application 8,701,577. It isintended for testing the allergic reaction of the skin test subject tovarious test substances and test liquids. These test substances and testliquids are each accommodated in a compartment of the testing device,which can be applied by means of the adhesive strip to a specificposition on the skin of a test subject. The test substances and testliquids are left to act on the skin for a predetermined period, e.g. 72hours, following which the testing device is removed again.

Since the test substances and test liquids are held captive between theskin and the compartments in question during the test, the influence ofthe individual different substances can be determined accurately.

In practice, the known testing device is used as follows: First of all,the removable protective strip adhering to the adhesive strip isremoved. The various test substances and test liquids are then placed inthe compartments which have now become free, following which the wholecombination is stuck on the skin of a test subject by means of theadhesive strip. In the process the test substances and test liquids inthe compartments come into contact with the part of the skin which iscovered by the compartment in question. This last factor is veryimportant for accurately determining the influence on the skin of eachof the various substances individually.

However, with the use of this known testing device the problem occursthat the placing of the test substances and test liquids in thecompartments does not always take place equally accurately, owing to theinaccuracy of the metering devices/hypodermic needle holders for thesubstances and phials for the liquids. The test substance or test liquidis sometimes spilled on the adhesive strip, as a result of which theallergic reaction does not remain limited to the "test area" and theadjacent skin can also be affected. If another substance also happens tobe spilled on the adhesive strip, there is a risk of the varioussubstances becoming mixed, which means that a reliable result can nolonger be obtained. Besides, in such a case the test can no longerreasonably be carried out, because the adhesive layer of the plaster haslost its effectiveness.

SUMMARY OF THE INVENTION

The object of the invention is therefore to provide a diagnostic testingdevice of the type described above, which does not have thisdisadvantage, and in the case of which it can always be ensured that thetest substances and test liquids are situated only in their appropriatecompartments. This is achieved according to the invention in that at theposition of each compartment the protective strip is provided with anopening corresponding essentially to the compartment. This means thatthe compartments are accessible through the protective strip, while thewhole of the remaining part of the adhesive strip is screened off by theprotective strip.

If a certain part of the test substances and test liquids is spilledduring placing in the compartments, this part falls onto the protectivestrip. Before the testing device is applied to the skin, the protectivestrip is removed, in which case any test substances and test liquidsspilled on it are also removed. The exposed adhesive strip is completelyfree of spilled substances, and compartments filled with test substancesand test liquids in the correct manner can be applied directly to theskin. In the case of the testing device according to the invention it istherefore ensured at all times that the skin is brought into contactwith the various test substances and test liquids only at the positionof the compartments. The user-friendliness of the testing device isconsequently considerably greater than that of the known device both forthe wearer and the doctor or his or her assistant. The product is alsoeasier to handle due to the fact that the adhesive layer is in factexposed only when the testing device is applied to the skin.

Each compartment preferably has a plate-shaped bottom which is fixed tothe adhesive strip and has a raised edge surrounding the bottom, andeach opening in the protective strip is of a shape corresponding to theperiphery of the edge. The compartments in this case project with theiredge through the protective strip.

In practice, several substances are preferably tested simultaneously.For this, one or more rows of compartments are provided on the adhesivestrip, and the protective strip has a corresponding number of rows ofopenings.

The compartments are preferably not interconnected, in such a way thatthe protective strip rests over its entire surface against the adhesivestrip. In the case of the unknown testing device the compartments areinterconnected by bridges, which means that the protective strip cannotrest against the adhesive strip at that point. According to theinvention, it is now ensured that the whole surface of the adhesivestrip outside the compartments is protected against drying out, in sucha way that good adhesion of the adhesive strip to the skin can beobtained.

As regards the known product, the philosophy is that the compartmentmust be of such a capacity that it can hold at least 100 microliters oftest substance/test liquid. If it is a solution in water, thecompartment preferably contains a carrier material, such as a piece offilter paper for absorbing the test liquid. In the case of testmaterials which are not water-soluble, the test material is placed inthe test compartment as a mixture with vaseline.

It has been found that it is sufficient to place only half or almost aquarter of the quantity of test substrate used hitherto in thecompartments of the testing device according to the invention. In thisway a good test result is obtained with a quantity of, for example, 30μl.

The shape of the raised edge of the compartments must be such that afterplacing on the skin a good containment is achieved. It goes withoutsaying that leakage of the compartments after application to the skinproduces undesirable reactions of the skin and makes assessment of thetest result difficult.

The edge of the compartments is to this end preferably rounded off incross-section, the rounding being stronger on the inside of the edgethan on the outside.

An advantage of the rounding on the outside of the edge is a greatercomfort for the wearer. In this respect an even greater improvement canbe obtained if the plate is square and has rounded corner points, andthe edges have correspondingly rounded corner points.

In an alternative embodiment, it is known to dispose a layer providedwith at least one opening on the adhesive strip, which opening togetherwith the adhesive strip forms a compartment. The invention can also beused in this testing device by ensuring that the openings in the layercoincide with the openings in the protective strip.

The compartments can be protected from external influences before use byproviding a covering, detachable cover strip at the sides facing awayfrom the adhesive strip.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be explained in greater detail below with referenceto the drawings, wherein:

FIG. 1 shows a view in perspective of the testing device according tothe invention, in which the protective strip is partially removed.

FIG. 2 shows a side view, partially in cross-section, of the deviceaccording to FIG. 1.

FIGS. 3a, 3b show details of a compartment.

FIG. 4 shows a view in perspective of the testing device according toanother embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The device shown in FIGS. 1 and 2 comprises an adhesive strip 1, towhich an adhesive 2 is applied. A number of compartments 3 are appliedin the same way as the adhesive 2, said compartments having a bottom 5and a raised edge 6 surrounding it. A test substance, which may or maynot be applied to a piece of filter paper, is placed in the recessformed by the bottom 5 and the raised edge 6.

A protective strip 4, to protect the adhesive 2 from drying out, isapplied to the adhesive layer 2 of the adhesive strip 1. The protectivestrip 4 is provided with openings 7, the position and dimensions ofwhich correspond to those of the compartments 3. It will be clear thatwhen a test substance is being placed in the various compartments aquantity of substance may be spilled on the protective strip 4, and willnot reach the adhesive strip 1. As soon as the protective strip 4 isthen removed from the adhesive strip 1, the spilled substance is alsoremoved, with the result that an entirely clean adhesive strip 1 remainsand can be applied directly to the skin.

A detachable cover strip 9, which is joined to the protective strip 4 bymeans of adhesive edges 10, can be provided on the top of thecompartments 3. The compartments 3 are in this way protected well fromexternal influences before use.

The testing device also has a lengthwise running dividing line 8, insuch a way that two rows of five compartments each, with their ownadhesive strip can be formed.

In the compartment shown in FIGS. 3a and 3b the edge 6 is designed incross-section with a fairly great curvature on the inside 11, forexample with a radius of curvature of 0.2 mm. The curvature on theoutside 12 is less great, for example having a radius of curvature of0.8 mm.

In top view the corners 13 of the compartment are rounded. The roundedcorners provide the wearer with greater comfort.

FIG. 4 shows a view in perspective of the testing device according tothe invention, in which the protective strip 4 is provided with a cut 14near one of its perpheral sides. This cut 14 makes it possible to removethe protective strip easily in two parts from the adhesive strip. Ofcourse, it is also possible for the protective strip to be provided witha cut which is in the center for example, and not near one of itsperipheral sides. However, the latter embodiment has the disadvantagethat, due to the weight of the compartments, the device has a tendencyto sag along the lengthwise side at the position of the cut. This isundesirable, because a rounding in the device, which generally arisestowards the side where the cut is situated, detaches the protectivestrip to some extent from the adhesive material, which consequentlydeteriorates in quality through oxidation.

The test plaster can have rounded corners which increase the comfort forthe wearer.

The adhesive strip is preferably provided with an adhesive which isreadily tolerated by the skin. A porous acrylate copolymer which can betolerated by the skin is preferably used. The use of an adhesive whichis resistant to perspiration (so-called wet stick adhesives) isrecommended.

The adhesive strip generally comprises a non-woven textile or plasticmaterial and is, for example, colour corresponding to the colour of theskin.

The present invention is explained with reference to a diagnostictesting device, in which the compartments have a square plate-shapedbottom with corresponding edges. Instead of being square, thecompartments can, however, be of any desired shape, and can be, forexample, round or oval.

The advantages of the testing device according to the invention can besummarized as follows:

In the case of the known products the adhesive strip is to a greater orlesser extent detached from the protective strip, as a result of theheight of the raised edge of the compartments. This means that in asmall region around each compartment oxygen comes into contact with theadhesive on the adhesive strip. After a few weeks (of storage) havepassed, the adhesive force is greatly reduced, as a result of theoxidation which has occurred. Through the perforation of the protectivestrip at the position of the compartments, the device according to theinvention can be kept for a long time, for example a year. Theprotective strip lies completely tightly on the adhesive layer of thestrip around each compartment. Premature oxidation of the adhesive layeris consequently absolutely impossible.

Devices of the present type without protective strip are difficult tohandle. Such a device "hangs" over the palm of the hand and the fingers,while at the same time the compartments must be filled with a specifiedquantity of test substance or test liquid using injection devices whichin practice meter poorly. In the case of the device according to theinvention the protective strip need not be removed before thecompartments are filled. The firmness of the device as such means thataccurate filling of the compartments can be carried out in the optimumway, despite the often inaccurate working of the injection devices.

In the case of the known devices an excess of test substance or testliquid makes the device worthless, because the adhesive force of theadhesive strip is adversely affected. Besides, such an excess causesgreat inaccuracy of the test results. In the case of the deviceaccording to the invention an excess of test preparation can be removedfrom the protective strip in a simple manner, for example using a cottonbud. This means that an accurate preparation of the test is possible.

The preparation of extensive and large numbers of tests is impossible inthe case of the known devices having a protective strip, because onremoval of the protective strip the adhesion of the adhesive layer isreduced due to the oxidation discussed above. However, with the deviceaccording to the invention large and extensive tests for differentpatients can be prepared in an excellent manner in one go. The adhesivelayer remains in excellent condition due to the continual presence ofthe protective strip.

The storage of testing devices prepared in advance is not easilypossible in the case of the known devices. A large amount of storagespace is needed for the devices without protective strip, in order toprevent adhesion between them. The storage of a large number of testsprepared a long way ahead is readily possible with the device accordingto the invention. In practice, tests are often prepared for a wholeweek.

The devices according to the present type are often applied for a periodof, for example, 72 hours to the skin of the person being tested. In thecase of the known device it is often necessary to fix the test plasteradditionally by sticking on extra plasters. The device according to theinvention makes it possible to carry out 72-hours test with good resultswithout sticking on other plasters. The use of a wet stick adhesivemeans that the test plaster according to the invention retains itsadhesion, even if the test subject perspires heavily.

I claim:
 1. Diagnostic testing device for the skin comprising at leastone row of compartments, each compartment adapted to contain adiagnostic aid, an adhesive strip on which said at least one row ofcompartments is located, and a removable protective strip which is stuckto the adhesive strip at the same side as the compartments, saidprotective strip being provided with an opening at the position of eachcompartment, and said protective strip having number of rows of openingscorresponding to the number of rows of compartments.
 2. Testing deviceaccording to claim 1, wherein each compartment has a plate-shaped bottomwhich is fixed to the adhesive strip and has a raised edge surroundingthe bottom, and each opening in the protective strip is of a shapecorresponding to the periphery of the edge.
 3. Testing device accordingto claim 2, wherein the compartments are not interconnected, and theprotective strip rests over its entire surface against the adhesivestrip.
 4. Testing device according to claim 2, wherein the edge isrounded off in cross section.
 5. Testing device according to claim 4,wherein the rounding is greater on the inside of the edge than on theoutside.
 6. Testing device according to claim 5, wherein the plate issquare and has rounded corner points, and the edges have correspondinglyrounded corner points.
 7. Testing device according to claim 1, wherein alayer provided with at least one opening is situated on the adhesivestrip, which opening together with the adhesive strip forms acompartment, and openings in the layer coincide with the openings in theprotective strip.
 8. Testing device according to claim 1, furtherincluding a detachable cover strip for covering the compartments at theside facing away from the adhesive strip.
 9. Testing device according toclaim 1, wherein the protective strip has a cut near one of itsperipheral sides.